A Study to Evaluate Efficacy and Safety of Mosunetuzumab in Combination with Lenalidomide in Comparison to Rituximab in Combination with Lenalidomide in Patients with Follicular Lymphoma

Phase 1

• Conditions: Relapsed/refractory follicular lymphoma; MedDRA version: 21.0Level: PTClassification code 10016906Term: Follicle centre lymphoma, follicular grade I, II, III refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005239-53-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Age >=18 years at the time of signing Informed Consent Form
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Histologically documented CD20 + follicular lymphoma (FL) (Grades 1-3a)
Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL
Adequate hematologic function (unless due to underlying lymphoma, per the investigator)
Normal laboratory values
Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after the final dose of rituximab
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 28 days after the final dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab and 12 months after the final dose of rituximab
For patients enrolled in the extended China enrollment phase at National Medical Products Administration (NMPA)-recognized sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Grade 3b FL
History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
Prior standard or investigational anti-cancer therapy
Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=1 (per National Cancer Institute Common Toxicity Criteria for Adverse Events Version 5.0 [NCI CTCAE, v5.0]) prior to Day 1 of Cycle 1
Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
History of solid organ transplantation
History of severe allergic or anaphylactic reaction to humanized, chimeric or murine MAbs
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, lenalidomide, or thalidomide formulation, including mannitol
History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis
Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
Active Hepatitis B or C infection
Known history of human immunodeficiency virus (HIV) positive status
History of progressive multifocal leukoencephalopathy (PML)
Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
Other malignancy that could affect compliance with the protocol or interpretation of results
Active autoimmune disease requiring treatment
History of autoimmune disease
Prior allogeneic stem cell transplant (SCT)
Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease or significant pulmonary disease
Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
Pregnant or lactating or intending to become pregnant during the study
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified